RecruitingNot ApplicableNCT06152107

A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema


Sponsor

Shanghai Chest Hospital

Enrollment

100 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a procedure called bronchoscopic thermal vapor ablation (BTVA) — a minimally invasive treatment delivered through a breathing tube — for people with severe emphysema (a type of COPD where the air sacs in the lungs are permanently damaged). The procedure uses steam to treat specific areas of the lung, aiming to improve breathing. **You may be eligible if...** - You are 18 years or older - You have severe emphysema and specific treatable areas in your lungs identified by CT scan - You have not smoked for at least 2 months and will not smoke during the study - Your lung function tests show severe obstruction (FEV1 between 15% and 50% predicted) - You can walk at least 140 meters in 6 minutes - You experience significant breathlessness (mMRC score ≥ 2) **You may NOT be eligible if...** - You have had a recent heart attack, very low heart function, or serious heart rhythm problems - You have active bleeding in the airways, blood clotting disorders, or severe lung high blood pressure - You have recently had a COPD flare-up (within the past 6 weeks) - You have had previous lung surgery, lung volume reduction surgery, or lung transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBTVA treatment plus optimal medical therapy (GOLD guidelines)

Patients in experimental group will be treated with the InterVapor System in at least 2 subsegments of different segments(unless the two most severe subsegments are located in the same segment). Patients in control group will be treated with the InterVapor System in at least 1 segment. A sequential procedure allows for at least 6 weeks and no longer than 6 months after the first procedure. Patients in both groups will receive ipsilateral hemithorax treatment per procedure, with a treatment volume (air + tissue) of ≤1700 mL per procedure and ≥1000 mL cumulatively across two procedures. All patients will continue to receive optimal medical therapy (GOLD guidelines) for the duration of the study. Follow-up visits will be scheduled at 1, 3, 6 and 12 months following the second procedure with examination of pulmonary function tests, HRCT, 6-minute walk test, SGRQ-C, mMRC, CAT questionnaires. All adverse events during the study will be recorded.


Locations(9)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Emergency General Hospital

Beijing, China

West China Hospital of Sichuan University

Chengdu, China

Linyi People's Hospital

Linyi, China

Jiangxi Provincial People's Hospital

Nanchang, China

Shanghai Chest Hospital

Shanghai, China

Shanghai Sixth People's Hospital

Shanghai, China

Hebei Provincial People's Hospital

Shijiazhuang, China

Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

Zhejiang, China

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NCT06152107


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